Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834561 | Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions | PHASE1 | COMPLETED | 32 | — | — | Jan 1, 2002 | Feb 1, 2002 | Aug 19, 2024 | 1 | Canada |
| NCT00835263 | Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions | PHASE1 | COMPLETED | 32 | — | — | Jan 1, 2002 | Feb 1, 2002 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Lamotrigine | EXPERIMENTAL | Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period |
| Lamictal® | ACTIVE_COMPARATOR | Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Lamotrigine | DRUG | 200 mg Tablet |
| Lamictal® | DRUG | 200 mg Tablet |
Inclusion Criteria * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Female Subjects will be post-menopausal or surgically sterilized. * Post-menopausal status is defined as absence of menses for the past 12 months, * Sterile status is defined as hysterectomy, bilat...